The efficacy of topical imiquimod in high-grade cervical intraepithelial neoplasia: A systematic review and meta-analysis

Int J Gynaecol Obstet. 2024 Jan;164(1):66-74. doi: 10.1002/ijgo.14953. Epub 2023 Jun 23.


Objective: A major side effect of cervical excision for high-grade cervical intraepithelial neoplasia (CIN) is premature birth. A non-invasive treatment for reproductive age women is warranted. The aim of the present study was to determine the efficacy of topical imiquimod in the treatment of high-grade CIN, defined as a regression to ≤CIN 1, and to determine the clearance rate of high-risk human papillomavirus (hr-HPV), compared with surgical treatment and placebo.

Methods: Databases were searched for articles from their inception to February 2023.The study protocol number was INPLASY2022110046. Original studies reporting the efficacy of topical imiquimod in CIN 2, CIN 3 or persistent hr-HPV infections were included. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist.

Results: Five studies were included (n = 463). Histological regression to ≤CIN 1 was 55% in imiquimod versus 29% in placebo, and 93% in surgical treatment. Imiquimod-treated women had a greater odds of histological regression to ≤CIN 1 than placebo (odds ratio [OR] 4.17, 95% confidence interval [CI] 2.03-8.54). In comparison to imiquimod, surgical treatment had an OR of 14.81(95% CI 6.59-33.27) for histological regression to ≤CIN 1. The hr-HPV clearance rate was 53.4% after imiquimod and 66% after surgical treatment (95% CI 0.62-23.77).

Conclusions: The histological regression rate is highest for surgical treatment followed by imiquimod treatment and placebo.

Keywords: LLETZ; metabolic clearance rate; papillomaviridae; papillomavirus infections; squamous intraepithelial lesions; transformation zone; treatment outcome; uterine cervical neoplasms.

Publication types

  • Meta-Analysis
  • Systematic Review
  • Review

MeSH terms

  • Cervix Uteri / pathology
  • Female
  • Humans
  • Imiquimod / therapeutic use
  • Papillomaviridae
  • Papillomavirus Infections*
  • Uterine Cervical Dysplasia* / pathology
  • Uterine Cervical Neoplasms* / drug therapy
  • Uterine Cervical Neoplasms* / pathology
  • Uterine Cervical Neoplasms* / surgery


  • Imiquimod